Project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals

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Project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals 9 th Meeting of the Harmonization Steering Committee 24 March 2010, WHO Headquarters, Geneva,

1 Project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals 9 th Meeting of the Harmonization Steering Committee 24 March 2010, WHO Headquarters, Geneva, Switzerland Meeting Record Welcome and Opening of the Meeting 1. The 9 th Meeting of the WHO/IPCS Harmonization Steering Committee was held at the Headquarters of the World Health Organization, Geneva, Switzerland, on 24 March The meeting was opened by the Chair of the Committee, Dr Margaret Hartley at 9.30 am. The Chair spoke about the WHO/IPCS Meeting on Strengthening Global Collaboration in Chemical Risk Assessment, held on March 2010, which the present meeting participants had attended. A number of proposals for further international work on risk assessment methodologies had been made, some of which may be appropriate for the Harmonization Project. In addition the meeting had supported new ways of collaborating and the establishment of a WHO network of risk assessment bodies. She reminded participants that the 8 th Harmonization Steering Committee had recommended that consideration be given to the establishment of such a risk assessment network and invited the Committee to take the proposed network into account during its deliberations. 2. The List of Participants appears at Annex 1. Approval of the Agenda 3. The adopted agenda appears at Annex 2. Harmonization Project Status Report 4. The Secretariat introduced document WHO/IPCS/HSC-9/10.01 Harmonization Project Status Report. The report reviews implementation of Project activities included in the Workplan, which can be found in Document WHO/IPCS/HSC-9/10.2. The Secretariat reminded the Committee that its 8 th Meeting had recommended that work on new activities commence in a phased approach reflecting available resources. The Chair then invited each of the activity Page 1 of 10

2 Liaisons (or in the absence of a Liaison, the Secretariat) in turn to provide an overview for the activities. 5. The Committee noted that the following had been completed/published: Guidance on Data Quality in Chemical Exposure Assessment. Guidance on Characterizing and Communicating Uncertainty in Exposure Assessment. Report of the Berlin Workshop on Skin Sensitization in Chemical Risk Assessment. Guidance on Mutagenicity Testing for Chemical Risk Assessment. Framework for Analyzing the Relevance of a Non-Cancer Mode of Action for Humans. Investigation of the development of a WHO network of risk assessment bodies (meeting held March 2010). Many training/continuing education workshops relating to guidance on: exposure assessment, mode of action and chemical-specific adjustment factors. 6. The Committee noted that the following guidance had been released for public and peer review, and was in the process of being finalized: Framework for Risk Assessment of Combined Exposures to Multiple Chemicals. Engagement of partners, such as OECD, ECETOC and ILSI/HESI, in follow up activities including an international workshop was judged useful and effective. Principles of Characterizing and Applying PBPK Models. Human Health Risk Assessment Toolkit (pilot tested in three Asian countries and presented at regional events for Africa and for Latin America and Caribbean). 7. The Committee noted the following documents in preparation, prior to public and peer review, or activities underway: Guidance on immunotoxicity assessment (draft available, case studies in preparation). Guidance on uncertainty and variability in hazard assessment (thought-starter well developed, prior to first expert meeting). This will be coordinated with other related activities underway in the UK Food Standards Agency and under the umbrella of DG Sanco convened International Dialogue on Risk Assessment. Preparation for an international symposium on identifying early life stages for characterizing chemical exposures. Guidance on interpreting effects in toxicity studies that may be modest or adaptive (thought-starter in preparation). This is being coordinated with a related ILSI/HESI project. The Harmonization Project Training Group had been established and commenced work, but was not recently active. Page 2 of 10

3 8. The Committee noted the following status of the remaining activities: Expansion of mode of action frameworks to incorporate chemical-specific adjustment factors had not been undertaken. However a WHO meeting was being planned, involving key stakeholders, to develop a global "umbrella plan" for activities on Mode of Action, including the establishment of a Mode of Action Database. The meeting agreed that further work on mode of action is indicated to build on experience gained. A range of terms in use such as "mode of action" and "adverse outcome pathways" should be clarified in relation to each other. These issues should be discussed at the planned meeting. Development of guidance on problem formulation, priority setting and peer engagement had not been prepared. These issues had been presented and discussed at the Montreux Meeting on the Risk Assessment Toolkit, and some additional content will be included in the Toolkit. Ongoing input to the OECD project on interpretation of dermal absorption data. Ongoing maintenance work on terminology and harmonized morphological terminology for developmental toxicity (under the auspices of a WHO Collaborating Centre). 9. Key points made in the discussion that were of a general nature and relevant to more than one activity were: WHO has a role in "pinning down" the science at a moment in time, as well as a role in producing methodology guidance documents based on science that is sufficiently agreed. Need a process of review so that guidance is kept up-to-date. The proposed risk assessment network would be one mechanism for input to such reviews. Evaluation of the Project's impact relies on getting information about uptake and use of the guidance documents produced. Anecdotal information collected by the experts involved provides part of the picture, and the Committee requested an investigation of search tools that may be available to help complete picture. Website should be updated and a generic powerpoint presentation provided. 10. On the issue of training the meeting noted: A sustainable and holistic, rather than piecemeal, approach to training is needed. This could be facilitated through the proposed risk assessment network and should involve the Harmonization Training Group. Page 3 of 10

4 A number of upcoming events might provide opportunities for training/continuing education courses, including: International Conferences on Mutagenicity/Environmental Mutagens; 2012 IUTOX Congress on Toxicology in Developing Countries. Training/CEC materials should be linked to the Distance Learning Project (led by the Chulabhorn Institute in collaboration with WHO and Collaborating Centres at the Universities of Ottawa and Utrecht) as well as with the Human Health Risk Assessment Toolkit. A number of participants expressed interest in hosting training events on the Human Health Risk Assessment Toolkit. Reports from International/Supranational Partners on Activities Relevant to the Harmonization Project 11. Bob Diderich presented key OECD activities relevant to the Harmonization Project, identifying the following areas where input from WHO would be welcome: Guidance on QSAR and read-across (chemical categories). The meeting noted the relevance of mode of action and that the planned Imperial College meeting could assist in clarifying future collaboration. Establishment of a new database on pesticide metabolism in mammals. Guidance on use of (environmental) monitoring data in environmental risk assessment. Similar guidance relating to human health may be useful. Gathering simple environmental exposure tools. Something similar for human exposure may be useful. The meeting noted the usefulness of such tools for the Risk Assessment Toolkit. 12. Dr Steve Olin presented key ILSI activities relevant to the Harmonization Project: Framework on key-event dose-response, published in 2009, which could be incorporated in future into the WHO mode of action framework and would benefit from more case study work. Threshold of Toxicological Concern, which will be presented at the planned WHO OECD ILSI/HESI international workshop on combined exposures. Risk assessment of genotoxic carcinogens, including: use of margin of exposure; and intermittent and short term exposures. Risk 21 Project, addressing four key areas: 1) Exposure Science, 2) Dose- Response, 3) Tiered (Integrated) Testing, and 4) Cumulative Risk. Coordination with WHO/IPCS and other organizations will be essential. Integration of biomonitoring data into risk assessment (publication expected 2010). Framework for risk-benefit analysis of chemicals in food (EC funded project, due for publication in 2010). Page 4 of 10

5 13. The Chair thanked the presenters for their valuable contributions and suggestions which would be taken into account in future work planning for the Harmonization Project. Future Harmonization Project Activities 14. The meeting agreed that all Harmonization Project Workplan activities that had commenced, but had not been concluded, should be carried forward into a new workplan. The only activity on the Workplan that had not commenced related to problem formulation, priority setting and peer engagement. It was noted that good guidance is already available on problem formulation, such as in a National Academy of Science report. The issue that needs addressing is lack of application of problem formulation in the practice of risk assessment. Dr Peter Preuss offered to provide a draft of a US EPA document on problem formulation, when it becomes available. The Committee decided to defer consideration of work on this topic until then. 15. The Committee reviewed the outcomes of the WHO Meeting on Strengthening Global Collaboration in Chemical Risk Assessment relevant to the Harmonization Project, bearing in mind the Committee's "Aide for Consideration of New Projects". 16. The discussion identified that a number of proposed activities had already been included in the Harmonization Project, including: guidance on qualitative and quantitative methodologies for characterizing and expressing uncertainties in exposure and hazard assessment; guidance on risk assessment of combined exposures; and guidance for assessment and communication of (exposure) data quality. Additional awareness-raising about these activities would be useful. The Committee noted that some proposed activities are being addressed by other organizations, such as OECD. 17. The Committee recommended the following specific actions: Follow up work on the Risk Assessment Toolkit relating to: development of guidance for practical application of tiered approaches to assessment in developing countries, with examples (including use of exposure tools with limited data); and adapt existing developed country exposure scenarios to developing country needs/scenarios, i.e. to reflect country location-specific exposure conditions. The proposed international risk assessment network should be utilized as a valuable avenue to facilitate: sharing of work programmes on risk assessment methodology development; and the integration of new methodologies into risk assessment practice. To review the outcomes of the planned Imperial College meeting relating to incorporation of mode of action in QSARs and the development of a library of modes of action. To request the Imperial College meeting to consider the proposal to develop decision analysis tools for integrating data sources, because such tools may utilize mode of action concepts. Page 5 of 10

6 In order to avoid duplication of effort, to review the outcomes of a REACH project to develop guidance relating to the comparison of endpoints which are critical for risk assessment, i.e. identification of the most important endpoint. 18. In conclusion, the Secretariat was requested to prepare a new workplan for the Harmonization Project, and to bring back to the Committee at a future date those issues set aside at this point pending availability of additional inputs. Administrative arrangements 19. The Committee then considered its future administrative arrangements, bearing in mind the proposed establishment of an international network of risk assessment bodies including a "work area" on risk assessment methodology. It was agreed that the Harmonization Project should be placed under the umbrella of the network. The network would therefore provide a broader forum to discuss risk assessment methodology work and the Harmonization Steering Committee would no longer be needed. However the Committee agreed to retain a Harmonization Core Group and system of Liaisons (for each activity) because they had proved a very effective structure for sharing views and advice to assist the implementation of projects. 20. The Secretariat was requested to call for volunteers to be Liaisons for new activities, and to convene the Core Group and organize a teleconference when appropriate. At that time, the Core Group should elect its Chair. 21. The Secretariat thanked the outgoing Chair of the Harmonization Steering Committee, Dr Margaret Hartley, for her valuable contribution to the Project, her skill in facilitating productive and collaborative meetings, and her personal commitment and generosity in provision of advice and support. 22. After the customary exchange of courtesies the meeting was closed at Page 6 of 10

7 Annex 1 9th Meeting of the Harmonization Steering Committee 24 March 2010 List of participants Cristina Alonzo, Chemical Safety and Environmental Health Department, Uruguay Wagida Anwar, Ain Shams University, Egypt Edith Clarke, Ghana Health Service, Ghana Margaret Hartley, Australian Academy of Technological Sciences and Engineering Australia Matthias Herzler, Federal Institute for Risk Assessment, Germany Kathy Hughes, Health Canada, Canada Bette Meek, McLaughlin Centre for Population, Canada Peter Preuss, U.S. Environmental Protection Agency, USA Mathuros Ruchirawat, Chulabhorn Research Institute (CRI), Thailand Theo Vermeire, National Institute for Public Health and the Environment (RIVM), Netherlands SUPRANATIONAL ORGANIZATION REPRESENTATIVES Bob Diderich, Organisation for Economic Co-operation and Development (OECD), France Stephen Olin, ILSI Research Foundation, USA APOLOGIES The following Steering Committee members were invited but unable to attend: Page 7 of 10

8 Michael Bolger, US Food and Drug Administration, USA Bingheng Chen, Fudan University, People's Republic of China Ian Dewhurst, Health and Safety Executive, United Kingdom Tohru Inoue, National Institute of Health Sciences, Japan Sharon Munn, Institute for Health and Consumer Protection JRC, European Commission, Italy SECRETARIAT Carolyn Vickers, World Health Organization, Switzerland Page 8 of 10

9 INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY Project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals 9 th Meeting of the Harmonization Steering Committee 24 March 2010, WHO Headquarters, Geneva, Switzerland Room M605, Commencing at Annex 2 Adopted Agenda 1. Welcome and Opening of Meeting. The meeting will be opened by the Chair of the Committee, Dr Margaret Hartley. Secretariat announcements. 2. Approval of the Agenda 3. Harmonization Project Status Report Documents: WHO/IPCS/HSC-9/10.01 Status Report; Brochure A report on progress of current activities will be provided. 4. Reports from International/Supranational Partners on Activities Relevant to the Harmonization Project Powerpoint presentations OECD, EU institutions, ECETOC and ILSI will be invited to provide information on their recent and future work plans on risk assessment methodology, for the purpose of coordination and identification of issues relevant for the future Harmonization Project workplan. 5. Future Harmonization Project Activities Documents: WHO/IPCS/HSC-9/10.02 Brochure; Strategic Plan; Aide for consideration of new activities. First, the meeting will be requested to review the outcomes of the WHO Meeting on Strengthening Global Collaboration in Chemical Risk Assessment, with a view to identifying and discussing issues relevant to the Harmonization Project. Second, the meeting will be requested to recommend activities to be undertaken through the Harmonization Project over the next few years. The meeting will discuss implications for the Strategic Plan and Brochure. Page 9 of 10

10 1. Administrative arrangements Documents: WHO/IPCS/HSC-9/10.05 HSC ToR; Roles Arrangements for the Core Group and Project Liaisons will be settled. 2. Closure, at Additional Meeting Documents: List of Invited Participants Report of the 8 th Meeting of the Harmonization Project Steering Committee Page 10 of 10

Nanomaterials: Applications, Implications and Safety Management in the SAICM Context Rob Visser

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